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Second-line single-agent chemotherapy in human epidermal growth factor receptor 2-negative metastatic breast cancer:
Fabio Puglisi1, Daniel Rea2, Michel A Kroes3
1Department of Oncology, University Hospital of Udine, Piazzale S. Maria della Misericordia, n. 15, 33100 Udine, Italy; Department of Medical and Biological Sciences, University of Udine, Piazzale Kolbe, n. 3, 33100 Udine, Italy.
Background:
No 'gold standard' exists for single-agent chemotherapy of human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer (MBC) in the second-line. The objective of this systematic review is to identify and appraise overall survival (OS), progression-free survival (PFS), time to progression (TTP) and Grade ≥3 adverse event evidence for single-agent chemotherapy in this setting.
Methods:
MEDLINE, Embase and the Cochrane Library were searched to October 2013, and PubMed October 2013 to November 2014. Electronic database searches were supplemented with hand searching of reference lists and conferences. Eligible randomised controlled trials (RCTs) employed at least one single-agent chemotherapy treatment, enrolled HER2-negative or unselected MBC patients who had progressed following first-line chemotherapy within the metastatic setting, and reported outcomes of interest for the second-line setting.
Results:
Fifty-three RCTs were included in total, with most containing mixed populations by HER2 status and treatment line. Fourteen studies reported data specifically for second- and later-line treatment within the metastatic setting. Median overall survival (OS) in most trials was 8-13 months. Only one trial reported a significant difference between studied interventions in the second-line metastatic setting: nab-paclitaxel (n=131) conferred a statistically significant OS advantage vs. three-weekly paclitaxel (n=136) (median OS 13.0 vs. 10.7 months, respectively; hazard ratio 0.73, p=0.024) and improved overall safety.
Conclusion:
One RCT demonstrated significant benefit in this setting in confirmed HER2-negative MBC alongside favourable safety. Treatment line terminology was imprecise. To reliably inform patient treatment decisions, quality-of-life data are needed and precise OS estimation according to underlying patient characteristics.
Insights
Nab-paclitaxel showed improved overall survival and safety in HER2-negative metastatic breast cancer (MBC) second-line treatment. Further research is needed for quality-of-life data and precise OS estimation.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- No established standard of care for second-line single-agent chemotherapy in HER2-negative metastatic breast cancer (MBC).
- Need for evidence on efficacy and safety of single-agent chemotherapies in this patient population.
Purpose of the Study:
- To systematically review overall survival (OS), progression-free survival (PFS), time to progression (TTP), and adverse events (Grade ≥3) for single-agent chemotherapy in second-line HER2-negative MBC.
- To identify effective and safe treatment options for patients with advanced breast cancer.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) from MEDLINE, Embase, Cochrane Library, and PubMed up to November 2014.
- Inclusion criteria: single-agent chemotherapy, HER2-negative or unselected MBC patients progressing after first-line therapy, and reporting of key outcomes.
Main Results:
- Fifty-three RCTs were included; 14 provided data for second-line treatment.
- Median OS was generally 8-13 months across trials.
- One RCT showed nab-paclitaxel significantly improved OS (13.0 vs. 10.7 months) and safety compared to paclitaxel in HER2-negative MBC.
Conclusions:
- Nab-paclitaxel demonstrated significant OS benefit and favorable safety in a subset of HER2-negative MBC patients.
- Treatment line terminology in studies was often imprecise.
- Future research should include quality-of-life data and precise OS estimation by patient characteristics to guide treatment decisions.
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